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EC number: 239-350-6 | CAS number: 15308-01-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- December 09, 1985 to January 23, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented and reported study, conducted equivalent to internationally accepted technical guidelines in recognized industrial research organization. A quality assurance inspection report, but not a GLP compliance statement, was included in the study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- of 1981
- Deviations:
- yes
- Remarks:
- For the first induction the test substance was applied epidermally at a dose of approximately 0.4 g paste of test substance in vaseline for 24 h under occlusive dressing, instead of being administered by intradermal injection.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EU Directive 79/831 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- For the first induction the test substance was applied epidermally at a dose of approximately 0.4 g paste of test substance in vaseline for 24 h under occlusive dressing, instead of being administered by intradermal injection.
- Principles of method if other than guideline:
- The principles of the Guinea pig maximization test outlined in the OECD TGD 1981 and EU Directive 79/831 were followed, but for the first induction the test material was applied to the epidermis on filter patches (2 x 4cm) placed over the 4 injection sites at the neck into which 0.1 mL of freshly prepared adjuvant saline mixture/site had been injected intracutaneously. On this induction occasion the test material was applied epidrmally at a dose of approximately 0.4 g paste of test material in vaseline for 24 h under occlusive dressing, instead of being administered by intradermal injection. This deviation from the standard Guinea pig maximization test outlined in the OECD and EU TGDs accounted for the non-injectability of final formulations or insolubility of compounds in standard vehicles.
- GLP compliance:
- no
- Remarks:
- but Quality Assurance statement was included in the report
- Type of study:
- other: Modified Guinea pig maximization test
Test material
- Reference substance name:
- 2-chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide
- EC Number:
- 239-350-6
- EC Name:
- 2-chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide
- Cas Number:
- 15308-01-7
- Molecular formula:
- C14H10Cl3NO
- IUPAC Name:
- 2-chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide
- Details on test material:
- - Name of test material (as cited in study report): PBS 3248.3
- Appearance: solid
- Expiration date of the lot/batch: December 1986
- Stability under the condition of administration: not determined
- Storage conditions: dry, room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Toxicology GU 2.5, CIBA-GEIGY AG Basel
- Age at study initiation: Approximately 10 weeks
- Weight at study initiation: 306 – 415 g
- Housing: Individual housing in Macrolon cages (type III)
- Diet (ad libitum): Commercially available pelleted standard guinea pig diet (NAFAG No. 846, Gossau SG, Switzerland) supplemented with
fresh carrots.
- Water (ad libitum): Fresh water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 50 ± 10%
- Photoperiod: 12 hrs light/day
SENSITIVITY CHECK OF THE ANIMAL STRAIN
The sensitivity of the strain was controlled every six months with p - phenylenediamine.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: FCA/physiological saline mixture: intradermal; Test material: epidermal, occlusive
- Vehicle:
- other: vaseline (Demopharm SA., Bienne)
- Concentration / amount:
- 1st Induction:
ca. 10% in vaseline, i.e. approximately 0.4 g paste of test material in vaseline epidermally (i.e. epicutaneously) under occlusive dressing for 24 h.
2nd Induction:
ca. 10% in vaseline, i.e. approximately 0.4 g paste of test material in vaseline epidermally (i.e. epicutaneously) under occlusive dressing for 48 h.
1st and 2nd Challenge:
ca. 3% in vaseline (i.e. approximately 0.2 g paste of test material in vaseline), and vehicle (i.e. vaseline), occlusive epicutaneous administration for 24 h on contra-lateral flanks.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline (Demopharm SA., Bienne)
- Concentration / amount:
- 1st Induction:
ca. 10% in vaseline, i.e. approximately 0.4 g paste of test material in vaseline epidermally (i.e. epicutaneously) under occlusive dressing for 24 h.
2nd Induction:
ca. 10% in vaseline, i.e. approximately 0.4 g paste of test material in vaseline epidermally (i.e. epicutaneously) under occlusive dressing for 48 h.
1st and 2nd Challenge:
ca. 3% in vaseline (i.e. approximately 0.2 g paste of test material in vaseline), and vehicle (i.e. vaseline), occlusive epicutaneous administration for 24 h on contra-lateral flanks.
- No. of animals per dose:
- Control group: 10 male and 10 female guinea pigs
Test group: 10 male and 10 female guinea pigs - Details on study design:
- MAIN STUDY
1st Induction: Week 1
2nd Induction: Week 2
Each challenge: After a rest period of 14 days.
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: First induction 24 hours, second induction 48 hours
- Test group:
0.1 ml of 50% FCA/physiol. saline mixture injected intracutaneously at 4 sites of the animal's neck + occlusive dressing of test material/vaseline
paste over the 4 FCA/physiol. saline mixture injection sites.
- Control group: adjuvant + vehicle (vaseline),
- Site: animal's neck
Explanatory note: FCA =Freund's complete adjuvant
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: After a rest period of 14 days.
- Exposure period: 24 hours
- Test group: occlusive dressing of vehicle (vaseline) alone and test material/vaseline paste on contralateral flanks.
- Control group:
during 1st challenge: males vehicle alone, females vehicle on one flank, test material/vehicle paste on contralateral flank
- Evaluation (hr after challenge): 24 and 48 hours
The challenge application sites were chemically depilated before examination using Veet (R) for approximately 5 minutes.
24 and 48 hours after patch removal skin reactions were evaluated for erythema/eschar formation and edema according to Draize. In addition, scaling was recorded. - Challenge controls:
- A control group receiving adjuvant and vehicle during induction and vehicle and test material during the 1st challenge was included in the study, in order to check the maximum subirritant concentration of the test material in adjuvant treated animals.
- Positive control substance(s):
- yes
- Remarks:
- p - phenylenediamine: Sensitivity of the animal strain was controlled every six months.
Results and discussion
- Positive control results:
- Sensitivity of the animal strain was controlled every six months usng p - phenylenediamine as positive control substance. Corresponding results were not included in this end point study report.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle vaseline alone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle vaseline alone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 g of ca. 3% test material in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.2 g of ca. 3% test material in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle vaseline alone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle vaseline alone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 g of ca. 3% test material in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 g of ca. 3% test material in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle vaseline alone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle vaseline alone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g of ca. 3% test material in vaseline
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g of ca. 3% test material in vaseline. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Erythema and edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle vaseline alone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle vaseline alone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g of ca. 3% test material in vaseline
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema, in 1 animal associated with scaling
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 g of ca. 3% test material in vaseline. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Erythema and edema, in 1 animal associated with scaling.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle vaseline alone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle vaseline alone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g of ca. 3% test material in vaseline
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema, in 2 animals associated with scaling
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g of ca. 3% test material in vaseline. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: Erythema and edema, in 2 animals associated with scaling.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle vaseline alone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle vaseline alone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g of ca. 3% test material in vaseline
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema, in 5 animals associated with scaling
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 g of ca. 3% test material in vaseline. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: Erythema and edema, in 5 animals associated with scaling.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
The test material was tested for skin sensitization in guinea pigs equivalent or similar to the maximization test outlined in the OECD TGD 1981 and EU Directive 79/831. The principal deviation from these test guidelines was that for the first induction the test substance was applied epidermally (i.e. epicutaneously) for 24 h under occlusive dressing, instead of being administered by intradermal injection. For this purpose, ca. 10% test material in Vaseline, i.e. approximately 0.4 g paste, was administered on filter patches (2 x 4 cm) placed over the 4 injection sites at the neck into which 0.1 mL of freshly prepared adjuvant saline mixture/site had been injected intracutaneously. A vehicle control and a test group, each comprised of 10 male and 10 female guinea pigs, were included in the study.
Reliability grade 2 was assigned to the study. It was not conducted in compliance with GLP, but a quality assurance statement was included in the report. Sensitivity of the animal strain was controlled every six months using p – phenylenediamine as positive control agent, but corresponding results were not included in the study report.
During Week 2, the second induction was performed by occlusive, epicutaneous administration of ca.10 % test material in Vaseline for 48 hours. After resting periods of 14 days, challenge and re-challenge applications were performed by occlusive, epicutaneous administration of ca. 3 % test material in Vaseline (approximately 0.2 g paste per filter patch of 2 x 2 cm) on one flank and, for comparison, of Vaseline alone on the contralateral flank for 24 hours. The vehicle control group received adjuvant saline mixture and Vaseline during the induction period. During the first challenge, its males received Vaseline alone, its females Vaseline on one flank, test material/Vaseline paste on the contra-lateral flank, in order to check the maximum sub-irritant concentration of the test material in adjuvant treated animals.
Six of twenty and seven of twenty animals responded to the first and second challenge administrations of test material with erythema and edema associated with scale formation in a number of these responding animals. Skin reactions were not evident in animals of the test group on skin patches exposed to vehicle alone and also not in animals of the control group.
It was concluded that the test material has a skin-sensitizing (contact allergenic) effect, moderate in degree, in albino guinea pigs.
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